Regulatory Affairs Project Manager – (CMC) at Thermo Fisher, Apply Now!
Looking for a challenging career in CMC Regulatory Affairs? Thermo Fisher Scientific is hiring a CMC Regulatory Affairs Project Manager to lead Chemistry, Manufacturing, and Controls (CMC) development for therapeutic antibodies. If you have 5+ years of CMC project experience and strong project management skills, apply today to be part of a team that’s shaping the future of biopharmaceutical development.
Job Posting: CMC Regulatory Affairs Project Manager
Report to: CMC Project Management Leader
Key Accountabilities and Responsibilities for Regulatory Affairs:
- Responsible for achieving project goals, including timelines, budget, and scope.
- Translate the scientific strategy into a CMC project plan with support of the CMC leads for one or more drug development programs/projects, visualising timelines and dependencies between deliverables and define budget needs
- Track, monitor and report key milestones and decision points to drive delivery of projects in accordance with corporate objectives., balancing scope, cost, timelines and risk;
- Build strong working relationships with internal and external key stakeholders to ensure timely completion of CMC activities by continuously monitoring progress;
- Perform critical path analysis and risks, taking into account cross-functional interdependencies in the overall development project plan as Regulatory Affairs Project Manager.
- Coordinate on the delivery of those critical path items through prioritization setting where required and mitigate or escalate the risk together with the project team;
- Perform scenario simulations and advise on optimum development planning, as needed;
- Prepares and leads project team meetings including issuance of agenda, actions and meeting minutes to be documented, communicated and committed.
- Promote a culture of collaboration, cooperation, execution excellence, effective communication, and cross-functional problem-solving to enable a high-performing team.
Qualifications for Regulatory Affairs:
- Master degree in life-sciences;
- At minimum 5 years CMC project experience;
- Experience in working with biologics is a plus;
- Excellent planning and organizational skills, able to multi-task in a multicultural environment and prioritize,
- Strong analytical, problem solving and critical thinking skills with action-oriented follow through
- Experience working with CMC Teams and managing relationships with CMC vendors is strongly preferred and capable of building effective relationships
- Able to operate in a dynamic surrounding of a fast growing biotech company with challenging timelines;
- Quality conscious attitude;
- Demonstrated project management skills, responsiveness to issues, and passion for contributing to the development of new medicines
- Excellent communication skills
- A self-starter with the ability to work in a fast-paced environment and adapt quickly to changing needs and priorities;
- Fluent in English – our working language
Keywords: CMC Regulatory Affairs, Project Manager, Thermo Fisher Scientific, Job Posting
